CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 661 enrolled
Drug / intervention
lesogaberan (AZD3355) +4 moredrug
Likely dose
lesogaberan (AZD3355) 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01005251
NCT01005251Phase 2Completed
CompareCT.gov

Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI

AstraZeneca·interventional·Posted Oct 30, 2009·Updated Apr 25, 2011

In Brief

A Phase 2 clinical trial evaluating lesogaberan (AZD3355) and Placebo for Gastroesophageal Reflux Disease and 2 related conditions. Completed, enrolled 661 participants across 1 site.

Detailed Summary

This study is being carried out to see whether AZD3355 is an effective treatment as an add-on to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Another goal of the study is to examine which of the investigated doses of AZD3355 is optimal for treatment of these patients. This study will also measure levels of drug in the blood and see how well it is tolerated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux Disease, Heartburn, Regurgitation
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 30, 2009
Enrollment StartOct 1, 2009
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.7 years ago

Interventions

lesogaberan (AZD3355)drug

60 mg, oral, capsules, bid for 4 w

lesogaberan (AZD3355)drug

120 mg, oral, capsules, bid for 4 w

lesogaberan (AZD3355)drug

180 mg, oral, capsules, bid for 4 w

lesogaberan (AZD3355)drug

240 mg, oral, capsules, bid for 4 w

Placebodrug

oral,capsules, bid for 4 w